BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYALGAN

    MDR report key: 1696672 · Received May 21, 2010

    Report

    Report Number
    2410673-2010-00004
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    May 8, 2010
    Report Date
    May 21, 2010
    Manufacturer
    FIDIA FARMACEUTICI S.P.A.
    Product Code
    MOZ
    PMA / PMN Number
    950027
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL AND ADDITIONAL INFO WAS REPORTED BY A PHYSICIAN ON (B)96) 2010, AND (B)96) 2010: A (B)96) YEAR-OLD MALE INITIATED HYALURONATE SODIUM [HYALGAN] (DOSE AND THERAPY DATES NOT SPECIFIED) FOR OSTEOARTHRITIS OF THE KNEE. HE RECEIVED HIS SECOND INJECTION ON (B)(6) 2010. ON (B)(6)2010, THE PT DEVELOPED A FEVER, CHEST PAIN, AND SHORTNESS OF BREATH, AND WAS HOSPITALIZED WITH AN ADMITTING DIAGNOSIS OF IDIOPATHIC PERICARDITIS. AT THE TIME OF THE REPORT, THE PT WAS RECOVERING AT HOME AND THE SYMPTOMS HAD COMPLETELY RESOLVED. THE CARDIOLOGIST CLAIMED THAT PERICARDITIS WAS NOT RELATED TO THE HYALGAN INJECTIONS BUT TO A VIRUS. ON (B)(6) 2010, THE PT RECEIVED HIS 3RD INJECTION AND HIS 4TH INJECTION ON (B)(6) 2010 WITH NO PROBLEMS. LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. MEDICAL HISTORY INCLUDED HYPERTENSION, CHRONIC KIDNEY DISEASE, SLEEP APNEA, THYROID CANCER, PROSTATE CANCER, POLYCYTHEMIA VERA AND GOUT. CONCOMITANT MEDICATIONS INCLUDED ACETYLSALICYLIC ACID (ASPIRIN), ATENOLOL, HYDROCHLOROTHIAZIDE, FELODIPINE (PLENDIL), CANDESARTAN CILEXETIL (ATACAND), ALLOPURINOL AND COLCHICINE. NO FURTHER RELEVANT INFO REPORTED. PHARMACOVIGILANCE COMMENT: SANOFI-AVENTIS COMPANY COMMENT DATED (B)(6) 2010: THE EVENT OF PERICARDITIS WAS PROBABLY SECONDARY TO A VIRAL INFECTION (AS INDICATED BY A CARDIOLOGIST), SINCE THE PT RECOVERED AFTER THREE DAYS. ADDITIONAL INFO (E.G. LABORATORY/DIAGNOSTIC RESULTS TO CONFIRM ETIOLOGY OF INFECTION AND TREATMENT OF THE EVENT) IS NEEDED TO MAKE A COMPLETE MEDICAL AND CAUSAL ASSESSMENT OF THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYALGAN INTRA-ARTICULAR INJECTION MOZ FIDIA FARMACEUTICI S.P.A. NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization ATENOLOL| PLENDIL| ALLOPURINOL| ASPIRIN| COLCHICINE| ATACAND| HYDROCHLOROTHIAZIDE| PREV MEDS